Legal
Research by Rich Seifert on cloning and
other assisted reproductive technologies.

Legal Research
by Heather Burns on sperm and egg donors and host mothers.

Law
relevant to Reproductive Technologies

by
Christie Branson

Modern technology
permits
children to be born by involving more than two people. With these
technologies
there are several options:

The father can be
(1) the
supplier of the genetic material, (2) the husband of the supplier of
the female
genetic material, or (3) the husband of the woman who gestates the
child. The
mother could be (1) the supplier of the female genetic material, (2)
the wife
of the man who supplies the male genetic material, (3) the woman who
gestates
the child even though this woman did not supply any genetic material.

Statutory
Parental rights in CA generally (I did a general overview)

The parent-child
relationship
extends equally to every child and to every parent regardless of the
marital
status of the parent. Cal. Fam. Code §7602. Oddly enough this
definition is
only defining the relationship for support and visitation, not descent.

There is a
presumption that a
child of a wife co-habitating w/ the husband is the child of the
husband .Cal.
Fam. Code §7540. A presumption of paternity is given if the father
receives the
child into his home and openly holds out the child as his natural
child. Cal
Fam Code §7611

Blood tests may
be ordered to
determine paternity and over ride presumptions, except when the child
was conceived
by a surgical procedure (IVF) and the husband consented. Cal. Fam. Code
§7541.

Case
law involving Surrogate Mothers and interpretation of presumptions:

In re Marriage of
Moschetta
(1994, 4th Dist) 25 Cal App 4th 1218, 30 Cal Rptr 2d 893. This case
found that
in a traditional surrogacy, the husband and the biological mother (not
the
husband's wife) were the legal parents of the child. Under Fam. Code, §
7541(a)
genetic parenthood established by blood tests overcomes a presumption
Also, it
was undisputed that the wife was sterile, and Fam. Code, § 7540, only
applies
where the other spouse is not sterile. Although under Fam. Code, §
7611(d), a
person who receives a child into the home and openly holds out the
child as
natural is presumed to be the natural parent, the wife never held the
child out
as her natural child. Under the Uniform Parentage Act (of which Ca has
adopted), parentage was easily resolved in favor of the biological
mother, who
did not consent to adoption pursuant to Fam. Code, § 8814.

Where a surrogate
mother was
carrying an embryo created by anonymous parents, and neither the couple
contracting for the child nor the surrogate mother were genetically
related to
the child, the couple were deemed the child's parents. In re Marriage
of Buzzanca
(1998) 61 Cal. App. 4th 1410, 1421, 1428.

Is a surrogate
contract
valid?

In Johnson v.
Calvert, the CA
Supreme Court upheld the basic validity and enforceability of surrogacy
contracts although many think these contracts violate public policy.
Johnson v.
Calvert (1993) 5 Cal. 4th 84, 95. The court refused to acknowledge two
mothers
and resulted in determining who the legal mother was from who intended
to rear
the child. In Re Baby M, 542 A2d 52 (N.J. Super. Ct. Ch. Div. 1988) had
a
different result, finding a surrogate agreement against public policy.

Artificial
Insemination

If a woman is
artificially
inseminated with the semen of a man who is not her husband, her husband
is
treated in law as the natural father of the child thereby conceived.
Fam. Code
§ 7613(a). The artificial insemination must have been conducted under
the
supervision of a licensed physician and with the consent of the woman's
husband. The donor of semen provided to a licensed physician for use in
artificial insemination of a woman other than the donor's wife is
treated as if
he were not the natural father of the child. Fam. Code § 7613. The
woman just
needs to prove she gave birth to be the legal mother.

Common
Law Doctrines that may help parents claiming to have some right with
regards to
a child

No California
statute
authorizes a general proceeding by which any non-parent can obtain
parental
rights, such as custody or visitation. Curiale v. Reagan (1990) 222
Cal. App.
3d 1597 (no procedure by which a lesbian partner of a biological mother
can
obtain custody of or visitation with a child). In loco parentis (in
place of
parent) is a common-law doctrine that has been historically applied in
some
contexts to impose certain parental obligations and confer certain
parental
benefits on persons other than parents. Nancy S. v. Michele G. (1991)
228 Cal.
App. 3d 831. The term in loco parentis refers to any person who has put
himself
or herself in the situation of a lawful parent by assuming the
obligations
incident to the parental relationship without going through the
formalities
necessary to the establishment of a legal relationship of parent and
child. It
embodies the two ideas of assuming the parental status and discharging
the
parental duties.

Some cases have
stated or
implied that one standing in loco parentis is entitled to all the
rights of a
parent. Trudell v. Leatherby (1931) 212 Ca. 678. However, courts have
not been
willing to apply this doctrine because modern courts have generally
been
unwilling to broaden the meaning of "parent" in a statute unless
clearly intended by the Legislature. In re Jodi B. (1991) 227 Cal. App.
3d
1322.

A de facto parent
is a person
who has assumed, for a substantial period and on a day-to-day basis,
the role
of parent, fulfilling both the child's physical and psychological
needs. This
is a foster parent; for example. In re B.G. (1974) 11 Cal. 3d 679. As
with in
loco parentis, there has been a judicial reluctance to extend de facto
parentage into other areas. Nancy S. 228 Cal. App. 3d 831. There is no
procedure by which one can be declared a de facto parent, thereby
becoming
entitled to all of the rights and obligations of the parent-child
relationship.

While courts have
been
unwilling to expand the scope of parentage beyond what is contained in
the
statutes, the area of the law is exceedingly ripe for change, and
practitioners
should not assume that the current authorities will survive challenge
in the
future. Nontraditional situations, such as in vitro fertilization,
surrogate
parenting, artificial insemination, gay and lesbian adoptions, and
successive
relationships in which a stepparent is more a parent in fact than the
biological parent, are becoming more prevalent and accepted. When
coupled with
the policy that the custody be viewed from the perspective of the
child's best
interests, it is exceedingly artificial not to recognize de facto
parents.

Adoption is
probably the best
way to solve any of these problems arising because of presumptions, the
only
problem is getting consent from the biological parent(s).

Custody

A parent's
interest in the
custody of his or her children within the protection of the federal
due-process
and equal-protection clauses. This constitutional right underlies the
parental
preference doctrine, found in Family Code Section 3040(a)(1) which
gives first
preference to parents over non-parents in determining the custody of a
child.

The right of
custody has two
components; legal custody and physical custody. Legal custody refers to
the
right and the responsibility to make the decisions relating to the
health,
education, and welfare of the child. Fam. Code §§ 3033, 3006. Physical
custody
refers to with whom the child actually resides. Fam. Code § 3007.

The court's
permanent custody
order is made according to the child's best interests despite a
different
temporary order or a stipulation of the parties. In re Marriage of
Lewin (1986)
186 Cal. App. 3d 1482.

Intestate
Succession

The CA probate
code considers
children born out of wedlock differently than those born in wedlock.
Generally,
they are still considered kids of the natural parents under Cal probate
§6450(a). When these kids want to inherit from their nonmarital
parents, if its
mom they want to inherit from, they need to show she gave birth. If
it's the
dad they want to inherit from, they need the following:

1. Rebuttable
presumption of
paternity under family code.

2. Ct judgment of
paternity
during dad's lifetime AND

3. Paternity is
established
by clear and convincing evidence that dad has held kid out as his own.

When parents want
to inherit
from nonmarital kids it is generally not allowed unless a parent or
relative of
parent acknowledged child AND a parent or a relative of parent
contributed to
support or care of child. Cal. Probate §6452

A child whose
paternity is
determined by the 'married presumption' cannot inherit by intestacy
from a man
who (rather than the mother's husband) is alleged to be the actual
biological
father of the child. Estate of Cornelious (1984) 35 Cal. 3d 461,
464-467.

Several months ago, the press reported that NIH had determined that
over 600
serious adverse events (SAEs) had occurred in gene therapy trials and
that the
vast majority of these were not reported to NIH in a timely fashion.
That
report led to serious concerns about investigator compliance with
reporting
requirements, as well as the underlying safety of adenoviral vectors.
It led to
requests for raw data, and the subsequent release by the NIH of raw,
nanalyzed
numbers - and of the report forms themselves. The end result was that
the
public was presented with a very different picture than the one
described in
subsequent communications with the National Bioethics; Advisory
Commission
(NBAC), the Recombinant DNA Advisory Committee (RAC), and this
Committee.

For instance, while its early report of 600+ (and, later, 900+) SAEs
made it
sound like gene therapy was a dangerous enterprise, NIH ultimately
concluded
that 91 % of these adverse events were unrelated to treatment.
Furthermore, NIH
and FDA have also determined that every SAE that must be promptly
reported to
FDA was, indeed, so reported.

This information should serve to reassure the public about both the
safety of
gene therapy studies and the universal nature of compliance with FDA
reporting
requirements. Unfortunately, it has been months since NIH and FDA
performed
this analysis, and it has still not been published.

We therefore suggest that the HHS should immediately prepare a written
report
describing the number and nature of SAE reports that have been received
by NIH
and/or FDA. Specifically, this report should state how many
NIH-reported -SAEs
were expected to occur as a result of the progression of the patients
illness
and how many were unexpected. The report should further indicate how
many of
the unexpected and related SAEs - which the law requires to be promptly
reported to the FDA - were indeed reported in accordance with this
requirement.
The report should provide an analysis of how many of these unexpected
adverse
events were possibly or probably caused by the use of a -gene therapy
product,
as well as the.-number of, such product-caused events that, resulted in
death.

While it is certainly the prerogative of the Congress to legislate,
gene
therapy is an area of emerging science and is one that lends itself far
more
productively to vigorous and continuous oversight. The fact is, as you
know far
better than I, that legislation is difficult and time-consuming to
change, and
the process was designed that way for sound and appropriate
reasons.Policies
and procedures that affect an evolving technology such as gene therapy
need to
be flexible enough to evolve with the science.

HEARING ON HUMAN CLONING AND RELATED ISSUES, July 22, 1997
First, attempts to create a human child using the new cloning
technology of
somatic cell nuclear transfer should not be permitted by anyone in the
public
or private sector, either in the laboratory or in a clinical setting.
This
prohibition is recommended not only because the technique currently is
medically unsafe to use in humans, but also because there are moral and
ethical
concerns about this prospect that will likely continue to be
deliberated and
reviewed well into the future.

Next, the use of somatic cell nuclear transfer in research on cloning
animals
should continue. This type of research is both acceptable and
beneficial to the
public. Existing animal welfare laws and regulations, including review
by
institution-based animal protection committees, are sufficient to
address our
concerns about animal
research.

Likewise, additional limitations should not be placed upon the cloning
of human
cells and DNA sequences using somatic cell nuclear transfer. These
research
efforts do not raise the same scientific and ethical issues that
surround the
possible creation of an entire human being in the laboratory.

Great progress in medicine and biotechnology is possible using new
genetic
techniques without entering the realm of cloning human beings.
Genetically
engineered mice have already revolutionized our ability to study
devastating
diseases such as breast cancer and immune system deficiency. Even
better animal
models for human disease, aiding research into new or improved
therapies, are
an exciting prospect stemming from the latest cloning methods.

The most immediate benefit is likely to be the faster, more efficient
production of therapeutic human proteins in the milk of transgenic farm
animal
species. These drug products of biotechnology have already aided
persons with
blood deficiencies and serious infections among other conditions. In
the
longer-term future, cloned animals might become a safe source of organs
for
transplantation in patients with heart, kidney or liver failure.

TEXT: Office of the House Majority Leader
Statement by House Majority Leader
Dick Armey.

Cloning humans is
wrong. It
should be banned permanently, without loopholes, throughout the United
States.
We can ban human cloning without undermining promising and ethical
health
research.

History provides
us with too
many examples of unethical research on human beings, in the name of
science and
progress. One need not dispute that benefits to some might result. But
is it
worth the cost in terms of human life and human dignity? In the
case of
cloning humans, the answer is no.

Indeed, every credible player in this debate claims to Oppose cloning
humans.
Then some of them add the word "but." For example, liberals like
Senator Kennedy and President Clinton solemnly assure us they oppose
"cloning a human child," but by this, they mean that they want to ban
the implantation of a cloned human embryo into a woman's
uterus--apparently a chimpanzee's
uterus would be acceptable--and then only for the next ten years. After
which,
it's open season. So you can make as many clones as you like, as long
as you
kill them. Obviously, these people are not sincere. They want to allow
human
cloning without appearing to do so.

And then there are the biotech and pharmaceutical industries. They too
say they
do not want to use cloning to create human embryos, but they want to do
"promising stem-cell research." To which I respond: Fine. But let us
be clear. The intentional destruction of living human embryos is
unethical and
unacceptable. If an embryo is dividing and developing, it is a member
of the
human family and deserves our respect. And destroying it is repugnant
to the
American public. The real question before us, then, is: Is there a way
to do
stem-cell research without destroying human embryos? Pending the
resolution of that question, I think we have no choice but to agree
that human
cloning should be banned, with no "buts."

Cal. Health & Safety Code § 24185 (West 2000).
(a) No person shall clone a human being.
(b) No person shall purchase or sell an ovum, zygote, embryo, or fetus
for the
purpose of cloning a human being.
(c) For purposes of this section, "clone" means the practice of
creating or attempting to create a human being by transferring the
nucleus from
a human cell from whatever source into a human egg cell from which the
nucleus
has been removed for the purpose of, or to implant, the resulting
product to
initiate a pregnancy that could result in the birth of a human being.M.C.L.A. 333.16274

333.16274. Prohibition of human cloning; exceptions; penalties; right
of
action; definitions
(1) A licensee or registrant shall not engage in or attempt to engage
in human
cloning.
(2) Subsection (1) does not prohibit scientific research or cell-based
therapies not specifically prohibited by that subsection.
(3) A licensee or registrant who violates subsection (1) is subject to
the
administrative penalties prescribed in sections 16221 and 16226 [FN1] and to the civil penalty prescribed in
section 16275.
[FN2]
(4)This section does not give a person a private right of action.
(5)As used in this section:
(a) "Human cloning" means the use of human somatic cell nuclear
transfer technology to produce a human embryo.
(b) "Human embryo" means a human egg cell with a full genetic
composition capable of differentiating and maturing into a complete
human
being.
(c) "Human somatic cell" means a cell of a developing or fully
developed human being that is not and will not become a sperm or egg
cell.
(d) "Human somatic cell nuclear transfer" means transferring the
nucleus of a human somatic cell into an egg cell from which the nucleus
has
been removed or rendered inert.

Karen Lombardi

LEGAL
RESEARCH—HUMAN
REPRODUCTIVE TECHNOLOGY

The prospect of
human cloning
has proven to be one of the more controversial issues of our time. For
many
years cloning had been the subject of science fiction novels, though
much doubt
existed as its practicability. In 1997, however, Scottish nationals
cloned
Dolly the sheep, and instantly changed the world in which we live
forever.

WHAT CLONING
REALLY IS

Despite the
potential breadth
of the subject matter, cloning has been defined very narrowly for legal
purposes. “Clone” refers to the practice of creating, or attempting to
create a
human being by a process known as Somatic Cell Nuclear Transfer (SCNT).
In this
process, the nucleus is removed from an egg cell, human or non-human,
and
replaced with the nucleus of a human cell taken from any source in the
human
body. The resulting product is used to initiate a pregnancy that could
result
in the birth of a human being. In short, cloning produces a cell or
embryo
genetically identical to its donor. Current legislation, both at the
federal
and state levels, has been broadly drafted to encompass not only the
specific
act of cloning but also any activity even remotely connected to the
process.

POTENTIAL USES

General sentiment
in regards
to cloning differs depending on the enumerated purpose of the activity.
Cloning
for reproduction has met violent public outcry, whereas the use of
cloning
technology in order to clone organs or other human tissue (therapeutic
cloning)
is more tolerated. In either situation, few Americans are completely
comfortable with the idea of cloning, and many vehemently oppose it for
altogether, claiming among other things, that any cloning is
“unethical.”
Overwhelmingly, those who argue against cloning rely on religious
arguments and
personal concepts of “God” to justify their position. Consequently,
this
subject stirs up an emotional response rather than an intellectual
debate,
which will ostensibly affect the direction of future legislation.

Though the use of
cloning to
produce children is prohibited throughout the country and parts of the
world,
it is this potential uses that receives overwhelming attention. Other
uses for
the technology could potentially include cloning for bio-medical
research, or
to avoid passing on a genetically inherited disease. More controversial
anticipated uses include providing alternative fertility treatment for
couples,
who are unable to have children naturally, or cloning of embryos for
in-vitro
fertilization (IVF) to require that fewer eggs be removed and an
increased
likelihood that a viable fetus will be brought to term.

POLICY

The floodgates, for
better or
worse, have been opened and the legal system has been flooded with
legislation in
an effort to control the uncontrollable. The topic of cloning even made
it into
the President’s State of the Union Address earlier this year. Though
certain
trends in legislation have been observable thus far, it is crucial to
recognize
the underlying emotions that are the driving force for both sides of
the
debate. Understanding what compels the general populous and politicians
alike
to side a particular way will give us some direction as to how this
technology
will merge with our legal system in the future.

For most people
fear is
justifiably the overwhelming force in this debate. Not only does this
technology potentially fly in the face of Christian beliefs, but it
requires
that we all ask of ourselves extremely difficult questions. Cloning has
made us
all pause to consider the point at which life actually begins, and
whether it
is nature or nurture that truly makes us who we are. The fact that we
have no
real answers to these questions leaves us facing the unknown; and it is
human
nature that tells us to fear and reject what we don’t understand. For
humans
over the centuries this behavior has been an effective defense
mechanism, but
looking to the future it may prove dangerous.

For others, the
insatiable
desire to understand and learn in the name science is a lifelong
passion, and
one which strongly influences their position in the debate. These
individuals
pursue science as a form of free speech, and see cloning as a
fascinating
prospect with tremendously positive potential. The fact remains that
cloning is
being explored by scientists (and Raelians) all over the world, despite
the
existence of laws; those who would like to see cloning be pursued
prefer a
world in which the technology is methodically studied in a controlled
environment.

These conflicting
drivers,
fear and the quest for knowledge, are conspicuous themes in existing
legislation. The American legal system at both federal and state levels
has
sought to prohibit cloning for the purpose of legislation, and strongly
regulate it for therapeutic reasons. Additionally, the international
community
has responded to the prospect of cloning and has taken steps to
regulate itself
on a global scale.

CURRENT
LEGISLATION

Many countries
worldwide,
including Germany and the United Kingdom have taken measures to ban
human
cloning, and others have demonstrated a desire to prevent human cloning
as
well. At the G7 Summit of Economic Countries in June of 1997, the
participants
indicated widespread concern and apprehension regarding the
consequences of cloning
technology. In particular it appears there is a worldwide fear and
concern over
how to proceed on the issue, but there is a strong consensus that
certain
unified legislation of some type must be enacted.

The United States
federal
government has been extremely proactive in enacting legislation and
exploring
issues related to cloning. Nine days after the Dolly was cloned,
President
Clinton organized the National Bioethics Advisory Commission (NBAC) to
examine
the potential benefits, dangers, and ethical issues related to cloning,
particularly human cloning. They were given ninety days to explore the
controversy and reach a recommendation. The Commission concluded that
as of
1997 human cloning was still unsafe and as such, should be prohibited.
Consequently,
the Cloning Prohibition Act of 1997 was enacted, a comprehensive
prohibition on
human cloning.

Current legislation
is
pending in both the House and the Senate which would ban cloning
altogether (2003
Cong. U.S. H.R. 534, and 2003 Cong. U.S. S. 245, respectively). President Bush strongly supports such
prohibition,
as he is convinced that human cloning for any purpose is “wrong and
unethical.”
These two bills are essentially identical, and would prevent cloning of
human
embryos for any purpose. This legislation is specifically pursued in
order to
prevent all potential abuses of the technology. The consequences for
violating
this proposed law would include a fine of up to $1,000,000 and 10 years
imprisonment.

Alternatively,
Senator
Feinstein has recently introduced The Prohibition
on
Cloning of Human Beings Act (2003 US S. 1611) that will
ban human
cloning for reproductive purposes, but would protect it for research
purposes.
Under Feinstein’s bill, human embryos could be legally created through
the
process of SCNT, and used for research purposes. This bill would take
cloning
further and allow research into infertility, genetic diseases, and
treatments.
Its main focus is to prohibit cloning and protect stem cell research.
Clearly,
this proposed legislation is inspired by science and the quest to
discover the
potential benefits of cloning, while averting undesirable uses for
cloning,
i.e. for reproductive purposes.

It is unclear which
approach
will prevail, but one can reasonably infer that in any case, cloning of
human
embryos for the express purpose of creating human children will be
rejected. It
is crucial in any case to recognize the strong distinction made by all
of the
proposed legislation; cloning of cells such as skin or other DNA, other
than
embryos for therapeutic purposes is explicitly permitted.

California has led
the pack
in enacting state legislation. It was the first state to enact a 5
yr-moratorium in 1997 to explore the issue in full. Subsequently, it
became the
first state to introduce legislation banning human cloning and related
research
(Cal. Bus & Prof. Code §2260.5, Cal. Health & Safety § 24185). Under current CA law, all human cloning is
banned,
and a civil penalty has been enacted as a penalty, not to exceed
$25,000 for an
individual and $1,000,000 for a corporation. Again, it is clear that
the state
legislation does NOT pertain to cloning of tissue or organs that would
not
result in cloning an entire human being. Many states have enacted some
type of
legislation banning cloning, though the penalties set by each state
further
demonstrate the variance of responses to the technology. In contrast to
CA’s
laws, New York not only imposes civil fines, but also evokes criminal
penalties. It creates grounds for license
revocation
if public funds are used and makes human cloning, for reasons other
than
medical or scientific research, a class D felony (S.B. 6538, 223rd
Annual
Leg. Sess. (2000).

VEHICLES FOR
REGULATION

In
the future, there are particular vehicles for legislation that will
likely be
used. First of all, the government is permitted to regulate activities
such as
cloning in order to protect the health, safety and ethics of the
American
people. Additionally, it is permitted under the Constitution to promote
human
dignity. Opponents of cloning argue that human dignity is threatened by
taking
away someone’s individuality, which satisfies the criteria in this
instance.
Conversely, the first amendment is the strongest argument in favor of
SCNT
research. The first amendment of the Bill of Rights protects freedom of
speech
and expression. Scientists argue that prohibiting this research would
be to
prevent freedom of expression and speech. Whether science is speech is
a
current controversy underway. The government cannot prevent
dissemination of
ideas in society, and in the past, it has been highly deferential to
science,
based on this rationale.

I. On Feb. 27, 2003, the US House of
Representatives voted
241 to 155 to ban all forms of human cloning per Human Cloning
Prohibition
Act of 2003.The bill now goes on to the Senate for a vote.

The Act bans all human cloning, including cloning
to aid
pregnancies or for medical research.It also criminalizes importing human cloned embryos or any part
thereof
with a fine of $1 million and 10 years in prison.

The bill is strongly supported by President Bush,
who vows
to veto any bill that doesn’t completely ban human cloning.

II. Alternative bill, HR 801 or Cloning
Prohibition Act
of 2003, proposed a more moderate
ban of
cloning for human embryos while allowing cloning technology for medical
research.However, it has been voted down
by the
House of Representatives.

IV. The FDA currently has jurisdiction over all
clinical
research using cloning technology.Existing statutory authorities are found to be sufficiently
broad to
encompass regulation of somatic cell and gene therapies and products.Gene therapy products are defined as
products containing genetic material administered to modify or
manipulate the
expression of genetic material or to alter the biological properties of
living
cells.

I. British Parliament passed the 1990 Human
Fertilization
and Embryology Act to permit
cloning to
create embryos for stem cell research, which was approved in Jan. 2001.Under this act, scientists will be able
to create cloned embryos for the purpose of extracting stem cells for
medical
research.

This Act was recently upheld against an attack by
anti-abortion groups in the House of Lords.

III. The European Union adopted the Convention
for the
Protection of Human Rights and Dignity of the Human Being with Regard
to the Application
of Biology and Medicine in 1997
which
prohibited the creation of human embryos for research purposes.

A. Subsequently, an Additional
Protocol on the Prohibition of Cloning Human Beings was added to the abovementioned Convention which banned creating “a human being
genetically
identical to another human being, whether living or dead”.

A very useful website to quickly find out the
policies
around the world regarding cloning; this is a database of global
policies on
human cloning and germ-line engineering:http://www.glphr.org/genetic/genetic.htm

Boutique lizards?Apparently, even the smallest of creatures has the desire and
the
ability to utilize sperm from different males to create the most
promising
offspring.She uses the sperm from
the largest males to create sons, thus ensuring that they grow up big
and
strong.

In deciding how to determine the paternity of a
child, the
British court system has decided that a man mistakenly made a father
via IVF to
the wrong couple is deemed to be the legal and biological father of the
child.http://news.bbc.co.uk/1/hi/health/2797369.stm